Raphael Pharmaceutical Inc. has announced positive results from a proof-of-concept clinical study evaluating its novel cannabinoid-based formula for the management of rheumatoid arthritis (RA). The single-group trial, involving 12 adult participants, demonstrated promising efficacy in reducing disease activity and improving patient-reported outcomes over an eight-week period. The results suggest a potential new approach to managing RA, a chronic autoimmune disease affecting millions worldwide.
The study, conducted under IRB approval and in compliance with FDA regulations, assessed the impact of a daily 0.5 mL dose of the cannabinoid formula on RA symptoms. Key findings revealed a 19.2% reduction in the Disease Activity Score (DAS28), a widely used metric for evaluating RA disease activity. This decrease reflects a shift from high to moderate disease activity among the participants. Notably, the proportion of participants in remission increased from 0% at baseline to 16.67% by Week 8.
Symptom Improvement and Patient Satisfaction
In addition to the reduction in DAS28 scores, participants reported significant improvements in pain-related symptoms. Negative pain outcomes decreased from 75% at baseline to 50% by Week 8. Morning stiffness, another common symptom of RA, also showed notable improvement, decreasing from 75% to 41.67% over the same period.
Patient feedback was overwhelmingly positive, with 83.33% of participants expressing a desire to continue using the product and 91.67% indicating they would recommend it to others living with RA. These high satisfaction rates suggest that the cannabinoid formula is well-tolerated and provides meaningful relief from RA symptoms.
Mechanism of Action and Future Directions
Raphael Pharmaceutical's cannabinoid formulation is derived from select non-psychoactive strains of cannabis and is designed to interact with the endocannabinoid system, activating cannabinoid receptors expressed by immune cells. This interaction is believed to reduce inflammation, a key driver of RA pathology.
Shlomo Pilo, Chairman and CEO of Raphael Pharmaceutical, stated, "The results of our proof-of-concept clinical study are very promising and underscore the potential of our formula to improve quality of life for those suffering from rheumatoid arthritis. We intend to build on this study to create a new, improved, and cost-effective treatment option."
The company plans to explore various development pathways, including potential partnerships with larger biopharmaceutical companies, to advance the manufacturing, marketing, and distribution of the final product. Raphael Pharmaceutical also intends to investigate the potential applications of its cannabinoid-based technology platform in other chronic inflammatory conditions, such as autoimmune diseases and chronic lung inflammation.
Rheumatoid Arthritis: An Unmet Need
Rheumatoid arthritis is a chronic autoimmune disease characterized by joint pain, inflammation, fever, and fatigue. The global prevalence of RA is expected to increase significantly in the coming decades, with estimates projecting an 80% rise from 18 million cases in 2020 to 32 million in 2050, according to a report published in The Lancet Rheumatology. Despite the availability of existing therapies, there remains a significant unmet need for more effective and better-tolerated treatments.
Raphael Pharmaceutical believes that its cannabinoid formula, if approved by the FDA, could offer an attractive alternative to existing RA therapies, some of which can produce pronounced side effects, be prohibitively expensive, or deliver inadequate efficacy.
